阅读说明：本技术 一种碳酸氢钠化合物 (Sodium bicarbonate compound ) 是由 王明 于 2019-10-18 设计创作，主要内容包括：本发明提供一种碳酸氢钠化合物,该化合物用粉末X射线衍射测定法测定,以2θ±0.2°衍射角表示在14.9°,18.3°,21.8°,25.5°,29.1°,30.1°,30.4°,33.3°,34.4°,39.0°,40.7°,44.5°,47.7°,56.9°处显示出特征衍射峰。本发明制备的碳酸氢钠化合物具有稳定性好、纯度高、杂质少的优点,而且工艺简单,收率高,重复性强,适合于工业化生产。(The present invention provides a sodium hydrogencarbonate compound showing characteristic diffraction peaks at 14.9 °, 18.3 °, 21.8 °, 25.5 °, 29.1 °, 30.1 °, 30.4 °, 33.3 °, 34.4 °, 39.0 °, 40.7 °, 44.5 °, 47.7 °, and 56.9 ° expressed by 2 θ ± 0.2 ° diffraction angles measured by powder X-ray diffractometry. The sodium bicarbonate compound prepared by the invention has the advantages of good stability, high purity, less impurities, simple process, high yield and strong repeatability, and is suitable for industrial production.)

1. A sodium bicarbonate compound characterized by an X-ray powder diffraction pattern as shown in figure 1 at 2 Θ ± 0.2 ° diffraction angles showing characteristic diffraction peaks at 14.9 °, 18.3 °, 21.8 °, 25.5 °, 29.1 °, 30.1 °, 30.4 °, 33.3 °, 34.4 °, 39.0 °, 40.7 °, 44.5 °, 47.7 °, and 56.9 ° as determined by powder X-ray diffractometry.

2. The sodium bicarbonate compound of claim 1, prepared by reacting sodium stannate with ammonium bicarbonate.

3. The sodium bicarbonate compound according to claim 1, wherein the preparation method comprises the following steps:

(1) adding ammonium bicarbonate into the saturated sodium stannate solution, stirring for reaction, performing suction filtration, and drying to obtain a crude sodium bicarbonate product;

(2) and adding the sodium bicarbonate crude product into water, stirring, filtering, and drying to obtain a sodium bicarbonate refined product.

4. The process according to claim 3, wherein the weight ratio of sodium stannate to ammonium bicarbonate in step (1) is 4:5, and the reaction is carried out at 40 ℃ for 1 hour with stirring.

5. The process according to claim 3, wherein after the completion of the reaction in the step (1), carbon dioxide is introduced for 1 hour, and water is concentrated under reduced pressure to one tenth in volume.

6. The preparation method according to claim 3, wherein the filter cake is dried at 40-50 ℃ in the step (1).

7. The process according to claim 3, wherein the weight ratio of sodium hydrogencarbonate to water in the step (2) is 4:1, and the mixture is stirred at room temperature for 1 hour.

8. The preparation method according to claim 3, wherein the filter cake in the step (2) is dried at 40-50 ℃.

9. A pharmaceutical composition comprising the sodium bicarbonate compound of any one of claims 1-8 and a pharmaceutically acceptable excipient.

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a sodium bicarbonate compound and a preparation method thereof.

Background

Sodium bicarbonate (sodium bicarbonate) of the chemical formula NaHCO3, also known as baking soda, white crystals, odorless, non-toxic, soluble in water and slightly soluble in ethanol, is mainly used as antacid, neutralizes gastric acid, reduces pepsin activity, relieves pain and promotes healing after oral administration.

Sodium bicarbonate is generally prepared by reacting sodium carbonate Na₂CO3, landine or off-spec soda, in fact as an accessory product of the soda production line, and the reaction during the production of sodium bicarbonate is as follows:

the core reaction of soda production:

NH₃+H₂O+CO₂→NH₄HCO₃

NaCl+NH₄HCO₃→NH₄Cl+NaHCO₃↓

and (3) calcining reaction of crude heavy alkali:

NH₄HCO₃→NH₃↑+H₂O↑+CO₂↑

NaHCO₃→Na₂CO₃+H₂O↑+CO₂↑

producing baking soda:

Na₂CO₃+H₂O+CO₂→NaHCO₃↓。

in the above preparation process, the main component of the crude heavy alkali is sodium bicarbonate, and the calcination decomposition of the crude heavy alkali is decarbonization. This is the reverse process to the recarbonation of baking soda. From the viewpoint of baking soda as a final product, such reciprocation is unreasonable, and there are problems of long production flow, complicated operation, and high energy and material consumption. This unreasonable production flow is now in use because: 1) the baking soda is still used as an accessory product of a soda production line, and the independence of the baking soda is not considered; 2) although most of the crude heavy alkali is sodium carbonate, the purity of the product is still quite far from the standard, and special treatment is still needed; 3) the sodium bicarbonate and the ammonium bicarbonate both have the property of easy decomposition, and the two are easy to form the isomorphous phenomenon and can not be separated by using the common washing method. However, no technical report for preparing sodium bicarbonate by directly using crude heavy alkali exists at present.

At present, sodium bicarbonate sold or made in the market contains a small amount of impurities such as sodium carbonate, chloride, iron salt and the like, and the sodium bicarbonate is easily decomposed in the preparation and drying processes to generate sodium carbonate, and the impurities such as the chloride, the iron salt and the like are not easily removed; therefore, a new preparation method of sodium bicarbonate is needed to be found, so that the obtained medicinal sodium bicarbonate meets the quality standard of Chinese pharmacopoeia, and has better purity and less adverse reaction.

Disclosure of Invention

The invention aims to develop and prepare a novel sodium bicarbonate compound product, and solves the problems of more impurities, low purity and the like of sodium bicarbonate raw material medicines in the current market. In order to solve the problems, the invention prepares a sodium bicarbonate compound.

The invention provides a sodium bicarbonate compound and a preparation method thereof.

The invention also provides a pharmaceutical composition containing the sodium bicarbonate compound.

The technical scheme of the invention is as follows:

a sodium bicarbonate compound having an X-ray powder diffraction pattern as shown in figure 1 at 2 Θ ± 0.2 ° diffraction angles showing characteristic diffraction peaks at 14.9 °, 18.3 °, 21.8 °, 25.5 °, 29.1 °, 30.1 °, 30.4 °, 33.3 °, 34.4 °, 39.0 °, 40.7 °, 44.5 °, 47.7 °, and 56.9 ° as determined by powder X-ray diffractometry.

A process for preparing sodium hydrogen carbonate compound is carried out by reacting sodium stannate with ammonium hydrogen carbonate. The method specifically comprises the following steps:

(1) adding ammonium bicarbonate into the saturated sodium stannate solution, stirring for reaction, performing suction filtration, and drying to obtain a crude sodium bicarbonate product;

(2) and adding the sodium bicarbonate crude product into water, stirring, filtering, and drying to obtain a sodium bicarbonate refined product.

As a preferred embodiment of the present invention, the weight ratio of sodium stannate to ammonium bicarbonate in step (1) is 4:5, and the reaction is carried out with stirring at 40 ℃ for 1 hour.

In a preferred embodiment of the present invention, after the reaction in step (1) is completed, carbon dioxide is introduced for 1 hour, and water is concentrated under reduced pressure to one tenth of the volume.

As a preferred embodiment of the invention, the filter cake in the step (1) is dried at 40-50 ℃.

As a preferred embodiment of the present invention, the weight ratio of sodium bicarbonate to water in step (2) is 4:1, and the mixture is stirred at room temperature for 1 hour.

As a preferred embodiment of the invention, the filter cake in the step (2) is dried at 40-50 ℃.

A pharmaceutical composition comprising a sodium bicarbonate compound of the present invention and a pharmaceutically acceptable excipient

The pharmaceutical composition also contains edetate disodium.

The pharmaceutical composition is a sterile injection prepared from sodium bicarbonate and edetate disodium. The specification contained 10 ml: 0.2g and 10 ml: 0.5 g.

Compared with the prior art, the invention has the following advantages:

1. the sodium bicarbonate compound provided by the invention has high purity and low content of impurities such as sodium carbonate, chloride, iron salt and the like.

2. The preparation method of the sodium bicarbonate compound provided by the invention has the advantages of simple process, high yield and strong repeatability, and is suitable for industrial production.

3. The pharmaceutical composition containing the sodium bicarbonate compound provided by the invention has good stability, so that the safety and effectiveness of medication are improved, and the incidence rate of adverse reactions is reduced.

Drawings

Embodiments of the invention are described in detail below with reference to the attached drawing figures, wherein:

FIG. 1 is an X-ray powder diffraction pattern of the sodium bicarbonate compound of the present invention.

Detailed Description

The following examples are further illustrative of the present invention and are in no way intended to limit the scope of the invention. The present invention is further illustrated in detail below with reference to examples, but it should be understood by those skilled in the art that the present invention is not limited to these examples and the preparation method used. Also, equivalent substitutions, combinations, improvements or modifications of the invention may be made by those skilled in the art based on the description of the invention, but these are included in the scope of the invention.